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Fluid Administration Set
Bracco Diagnostics Inc. · Model 000475 · UDI-DI 10815112020016
EYN
Prescription
10
510(k) clearances
9
Adverse events
3
Recalls
6
Facilities
Description
Large Bore Tubing Administration Set
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2019-08-09 | Medline Industries Inc | Samples in the identified lot were found to have incomplete or open packaging seals. |
| 2014-10-08 | Customed, Inc | Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.